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REGENXBIO (RGNX) Provides Update on RGX-314 & Begins New Program

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REGENXBIO Inc. (RGNX - Free Report) provided an update on the RGX-314 programs. The company also announced that a pivotal program for RGX-314 for the treatment of wet age-related macular degeneration (wet AMD) is now active. Further, the company announced a new program, RGX-202, a potentially best-in-class, one-time gene therapy for the treatment of Duchenne Muscular Dystrophy (DMD).

Shares of the company have increased 12.2% in the past year compared with the industry’s growth of 5.3%.

The company announced that ATMOSPHERE, the first of the two planned pivotal studies to evaluate RGX-314, is active and patient screening is ongoing. ATMOSPHERE will evaluate the efficacy and safety of RGX-314 in patients with wet AMD. The second pivotal study is expected to be similar in design to ATMOSPHERE and REGENXBIO anticipates initiating the study in the second half of 2021.

REGENXBIO completed an End of Phase II meeting with the FDA for RGX-314 to discuss the details of a pivotal program to support a biologics license application (BLA). Based on the discussions with the FDA, REGENXBIO plans to conduct two randomized, well-controlled studies to evaluate the efficacy and safety of RGX-314 in patients with wet AMD, enrolling approximately 700 patients in total. REGENXBIO expects to submit a BLA based on these studies in 2024.

Phase II studies for RGX-314 utilizing in-office, suprachoroidal delivery are ongoing. The company completed enrollment in the first cohort of the AAVIATE study. Enrolment of patients continues in Cohort 1 for ALTITUDE, a phase II study for the treatment of Diabetic Retinopathy (DR). REGENXBIO expects to report initial data from this trial in 2021.

The companyalso announced the development of a potential one-time gene therapy, RGX-202, for the treatment of DMD. The investigational new drug (IND) filing for the same is expected in mid-2021.

The company expects to end 2020 with $515-$530 million in cash, cash equivalents and marketable securities.

The company continues to advance its pipeline of innovative therapies in the clinic as well as manufacturing capabilities.

Zacks Rank & Stocks to Consider

REGENXBIO currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the healthcare sector include Alkermes Plc. ((ALKS - Free Report) ), Halozyme Therapeutics Inc. ((HALO - Free Report) ) and ASLAN Pharmaceuticals Ltd. (ASLN - Free Report) . While Alkermes and Halozyme carry a Zacks Rank #1 (Strong Buy), ASLAN carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Alkermes’ earnings per share estimates have increased from 48 cents to 52 cents for 2021 over the past 60 days. Shares of the company have increased 0.2% in the past one year.

Halozyme’s earnings per share estimates have increased from 85 cents to 92 cents for 2021 and from $1.66 to $1.72 for 2021 over the past 60 days.

ASLAN’s loss per share estimates have narrowed from 42 cents to 40 cents for 2020 and from 60 cents to 57 cents for 2021 over the past 60 days.

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